Statutory Instruments
2008 No. 2297
Medicines
F1The Veterinary Medicines Regulations 2008
Made
26th August 2008
Laid before Parliament
1st September 2008
Coming into force
1st October 2008
The Secretary of State is a Minister designated( 1 ) for the purposes of making Regulations under section 2(2) of the European Communities Act 1972( 2 ) in relation to measures in the veterinary and phytosanitary fields for the protection of public health.
The Secretary of State has carried out the consultation required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety( 3 ).
In accordance with section 56(1) of the Finance Act 1973( 4 ), the Treasury consent to the making of these Regulations.
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973.
F1 PART 1 Introduction
Title and commencement
F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Definition of “veterinary medicinal product”, interpretation and scope
F12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Products to which these Regulations do not apply
F13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F1 PART 2 Authorised veterinary medicinal products
Placing a veterinary medicinal product on the market
F14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacture of veterinary medicinal products
F15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The finished product
F16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Classification, supply and possession of the product
F17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administration of the product
F18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Importation of authorised veterinary medicinal products
F19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advertising the product
F110. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advertising of prescription products and products containing psychotropic drugs or narcotics
F111. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Defence of publication in the course of business
F112. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wholesale dealing
F113. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Feedingstuffs
F114. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exemptions
F115. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees
F116. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F1 PART 3 Records
Food-producing animals: proof of purchase of veterinary medicinal products
F117. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: records of administration by a veterinary surgeon
F118. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: records of acquisition and administration
F119. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: retention of records
F120. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records by a holder of a manufacturing authorisation
F121. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records by a holder of a wholesale dealer’s authorisation
F122. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of the receipt or supply of prescription products
F123. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of products administered to a food-producing animal under the cascade
F124. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F1 PART 4 Unauthorised veterinary medicinal products
Importation of an unauthorised veterinary medicinal product
F125. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Possession of an unauthorised veterinary medicinal product
F126. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of an unauthorised veterinary medicinal product
F127. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 5 Miscellaneous provisions, enforcement and offences
The Veterinary Products Committee
F128. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Veterinary Products Committee appeals procedure
F129. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals to an appointed person
F130. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exports
F131. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time limits
F132. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appointment of inspectors
F133. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of entry
F134. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of an inspector
F135. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of pharmacies
F136. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Obstruction
F137. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Improvement notices
F138. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals against improvement notices
F139. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of a court on appeal
F140. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Seizure notices
F141. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Publication
F142. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Penalties
F143. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Northern Ireland
F144. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocations and consequential amendment
F145. — (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(2) In section 1 of the Medicines Act 1971( 5 ) (fees), in subsection (3), for “as amended by the Transfer of Functions (Wales) Order 1969 have the same meanings in this section as in that Act as so amended” substitute “(as amended) have the same meanings in this section as in that Act (as amended)”.
Jonathan Shaw
Parliamentary Under Secretary of State
Department for Environment, Food and Rural Affairs
Dave Watts
Alan Campbell
Two of the Lords Commissioners of Her Majesty’s Treasury
Regulation 4(3)
F1 SCHEDULE 1 Marketing authorisations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 5(2)
F1 SCHEDULE 2 The manufacture of veterinary medicinal products
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 7
F1 SCHEDULE 3 Classification and supply, wholesale dealers and sheep dip
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 8
F1 SCHEDULE 4 Administration of a veterinary medicinal product outside the terms of a marketing authorisation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 14
F1 SCHEDULE 5 Medicated feedingstuffs and specified feed additives
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 15(4)
F1 SCHEDULE 6 Exemptions for small pet animals
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 16
F1 SCHEDULE 7 Fees
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OJ No. L31, 1.2.2002, p. 1.
1971 c.69 , as amended by section 21 of the Health and Medicines Act 1988 (c. 49) and S.I. 1994/3144 , 2004/1031 , 2005/2750 and 2006/2407 .